481 Participants Needed

WATCHMAN Device for Stroke Prevention in Atrial Fibrillation

(ASAP-TOO Trial)

Recruiting at 96 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Boston Scientific Corporation
Must be taking: Aspirin, Clopidogrel
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be suitable for a specific medication regimen of aspirin and clopidogrel after the device implant. It's best to discuss your current medications with the study team.

How does the WATCHMAN device treatment differ from other treatments for stroke prevention in atrial fibrillation?

The WATCHMAN device is unique because it is a small implant placed in the heart to physically block blood clots from forming in the left atrial appendage, reducing stroke risk without the need for long-term blood-thinning medication like warfarin. This makes it a valuable option for patients who cannot tolerate anticoagulants due to bleeding risks or other complications.12345

What data supports the effectiveness of the WATCHMAN device for stroke prevention in atrial fibrillation?

The WATCHMAN device has been shown to be at least as effective as warfarin (a common blood thinner) in preventing strokes and deaths in patients with atrial fibrillation, according to a study. It is particularly useful for patients who cannot take long-term blood thinners due to bleeding risks.12456

Who Is on the Research Team?

Jacqueline Saw - Centre for ...

Jacqueline Saw, MD

Principal Investigator

Vancouver General Hospital

Vivek Reddy, MD - Physician's Channel ...

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

MB

Maurice Buchbinder, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults with non-valvular atrial fibrillation who can't take blood thinners. They must be able to take aspirin and clopidogrel after getting the WATCHMAN device implanted, willing to consent, and commit to follow-up visits. Excluded are those needing certain surgeries soon, with severe heart issues or bleeding disorders, pregnant women, or those in conflicting studies.

Inclusion Criteria

I am legally old enough to participate in this study according to my local laws.
I can and will come back for all needed follow-ups.
Two doctors agree I can't take blood thinners by mouth.
See 4 more

Exclusion Criteria

My heart's pumping ability is significantly reduced.
The subject has a life expectancy of less than two years
I plan to undergo a surgery or procedure within 3 months after getting a WATCHMAN device.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the WATCHMAN LAAC Device implant or control treatment with single antiplatelet therapy or no therapy

7 days
1 visit (in-person) for device implantation or control treatment initiation

Follow-up

Participants are monitored for safety and effectiveness, including assessments for stroke, systemic embolism, and major bleeding

5 years
Scheduled follow-up visits as per protocol

What Are the Treatments Tested in This Trial?

Interventions

  • Single Antiplatelet Therapy or No Therapy (Control)
  • WATCHMAN LAAC Device Implant
Trial Overview The study tests the WATCHMAN Left Atrial Appendage Closure Device's safety and effectiveness in reducing stroke risk without standard blood thinners. Participants will either receive this implant plus a special medication regimen or no therapy as control.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: WATCHMAN (Device)Experimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The WATCHMAN left atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, but initial studies raised safety concerns leading to a 'not approvable' status from the FDA.
In the subsequent PREVAIL trial, while the device was eventually deemed to have benefits that outweigh risks, updated data indicated a higher incidence of ischemic strokes in the WATCHMAN group (13 strokes) compared to the control group (1 stroke), prompting further review of its safety profile.
Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy.Waksman, R., Pendyala, LK.[2015]
The WATCHMAN device offers a promising alternative to long-term warfarin therapy for patients with atrial fibrillation (AF) who are at high risk for embolic events but may face complications from anticoagulants, supported by medium-term efficacy and safety data.
This review highlights important technical aspects of WATCHMAN implantation, emphasizing its role as a well-studied option for nonvalvular AF patients who require oral anticoagulation therapy.
Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation.N Obeyesekere Mbbs Mrcp Fracp Fhrs, DM.[2020]

Citations

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. [2015]
Catheter ablation in combination with left atrial appendage closure for atrial fibrillation. [2021]
Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. [2020]
Left Atrial Appendage Occlusion Complicated by Appendage Perforation Rescued by Device Deployment. [2019]
Left atrial appendage closure device implantation in patients with prior intracranial hemorrhage. [2020]
6.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Left Atrial Appendage Closure -The WATCHMAN Device. [2020]
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